California-based clinical-stage biotechnology company Adcentrx Therapeutics announced on Monday that it has received approval from the US Food and Drug Administration (FDA) for the company's Investigational New Drug (IND) application for ADRX-0405 for the treatment of select advanced solid tumours.

ADRX-0405 is a next-generation antibody-drug conjugate (ADC) composed of a humanised IgG1 antibody targeting six-transmembrane epithelial antigen of the prostate 1 (STEAP1), a cell surface protein that is upregulated in prostate cancer and certain other cancers, yet has limited expression in healthy tissue.

Adcentrx says that its proprietary i-Conjugation technology platform is an important component in the design of ADRX-0405.

The planned first-in-human Phase 1a/b clinical trial of ADRX-0405 is an open-label, multicentre, non-randomised dose escalation and dose expansion study. It will involve patients with advanced solid tumours, including metastatic castration resistant prostate cancer. Primary objectives will be to characterise the safety and tolerability and to determine the optimal dose of ADRX-0405. The company anticipates the first patient to be enrolled in the fourth quarter of 20244, with an estimated initial data readout in the fourth quarter of 2025.